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FDA 510(k) Application Details - K963276
Device Classification Name
Thermometer, Electronic, Clinical
More FDA Info for this Device
510(K) Number
K963276
Device Name
Thermometer, Electronic, Clinical
Applicant
SAFETY 1ST, INC.
210 BOYLSTON ST.
CHESTNUT HILL, MA 02167 US
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Contact
PAUL A WARE
Other 510(k) Applications for this Contact
Regulation Number
880.2910
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Classification Product Code
FLL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/20/1996
Decision Date
12/06/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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